ERYTECH Pharma (Paris:ERYP) (NYSE Euronext Paris: FR0011471135 -
ERYP),a French biopharmaceutical company that develops
innovative treatments for acute leukemia and other oncology indications
with unmet medical needs, announces that an independent Data and Safety
Monitoring Board (DSMB) completed its first assessment of the company’s
Phase IIb study in Acute Myeloid Leukemia (AML) study and unanimously
recommended continuation of the trial without modification.

The GRASPA-ML study is a multicentre, randomized, controlled Phase IIb
trial evaluating efficacy and tolerability of GRASPA® in the treatment
of newly diagnosed AML patients over 65 years old that are unfit for
intensive chemotherapy. In this 123 patients study, one-third of the
patients receive the current standard treatment (low-dose cytarabine)
and two-thirds receive low-dose cytarabine plus GRASPA®. The study was
initiated in March 2013 and is performed in collaboration with Orphan
Europe (Recordati Group), ERYTECH’s partner for the commercialization of
GRASPA® in 38 pays European countries.

A DSMB is an external committee of independent clinical research experts
who review data in ongoing clinical trials with particular attention to
safety. The DSMB assessment was based on a pre-planned safety analysis
on the first 30 patients included in the study and with a minimum of 1
month follow-up. A second DSMB review is planned when 60 patients will
be treated in the study.

“We are very pleased to see that our first trial in AML is
progressing on track, with this first DSMB review confirming the safety
profile of the product. This trial will be a landmark in the field of
AML as it will be the first time that a large group of AML patients is
receiving repeated doses of an asparaginase-based product. The use of
asparaginase has to date been very limited in this indication due to the
toxicity of the current forms. Thanks to the encapsulation in the red
blood cells we are enabling the use of asparaginase in the treatment of
these very fragile patients”, comments Yann Godfrin, co-founder and
CSO of ERYTECH Pharma.

“The study, if positive, will broaden the scope of use of our GRASPA
product to AML, the most common type of acute leukemia and about 3 to 4
times larger than our first indication in Acute Lymphoblastic Leukemia.
The rapid enrollment we are observing in the study, with in the meantime
close to a third of the patients enrolled in the study, is a good
indication of the important unmet medical need in this very severe
indication”, adds Gil Beyen, Chairman & CEO of ERYTECH.

About Acute Myeloid LeukemiaAcute Myeloid Leukemia (AML) is
an aggressive form of leukemia (blood or bone marrow cancer) that is
characterized by a rapid and abnormal proliferation of myeloid precursor
cells. AML usually progresses quickly and, if not treated, can be fatal
within a few months. With about 34 000 new patients per year in Europe
and the US, AML is the most common type of acute leukemia. Affecting
mainly the adult and senior patient population that often cannot
tolerate the existing forms of asparaginase products, AML represents one
of the highest mortality rates among all type of cancers and an
important unmet medical need. The median age of patients affected by AML
is 67 years.

Created in Lyon in 2004, ERYTECH is a French biopharmaceutical company
providing new prospects for cancer patients, particularly those with
acute leukemia. Every year about 50,000 patients are diagnosed with
Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML), the
two forms of acute leukemia. Today, for about 80% of these patients,
mainly adults and relapsing patients, there is no adequate solution due
to the toxicity of existing treatments, representing a market
opportunity of more than EUR 1 billion. By encapsulating the
asparaginase enzyme in red blood cells, ERYTECH has developed GRASPA®,
an original and effective treatment that targets leukemia cells through
“starvation” while significantly reducing the side effects for patients,
and allowing all patients to be treated, even the most fragile ones.
GRASPA® is currently completing Phase III clinical development in Acute
Lymphoblastic Leukemia (ALL) and is in Phase IIb clinical trial in Acute
Myeloid Leukemia (AML). ERYTECH has concluded distribution partnership
agreements for Europe with Orphan Europe (Recordati Group), and with
TEVA for Israel. In the United States, ERYTECH is launching a Phase Ib
clinical trial in ALL, after having received approval from the US FDA.
GRASPA® benefits from the orphan drug status both in ALL and in AML.The
company is also developing other indications in solid tumors and certain
orphan indications outside oncology. ERYTECH has its own GMP-approved
and operational manufacturing site.

ERYTECH is listed on NYSE Euronext regulated market in Paris. (ISIN
code: FR0011471135, ticker: ERYP) and is part of the CAC Healthcare, CAC
Pharm. & Bio and Next Biotech indexes.

Forward-looking information

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respect to the financial situation, the results of operations, the
strategy, the project and to the anticipated future performance of
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but may or may not prove to be correct. Actual events are difficult to
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control. Therefore, actual results, the financial condition, performance
or achievements of ERYTECH, or industry results, may turn out to be
materially different from any future results, performance or
achievements expressed or implied by such statements, forecasts and
estimates. Documents filed by ERYTECH Pharma with the French Autorité
des Marchés Financiers (www.amf-france.org),
also available on our website (www.erytech.com)
describe such risks and uncertainties. Given these uncertainties, no
representations are made as to the accuracy or fairness of such
forward-looking statements, forecasts and estimates. Furthermore,
forward-looking statements, forecasts and estimates only speak as of the
date of the publication of this document. ERYTECH disclaims any
obligation to update any such forward-looking statement, forecast or
estimates to reflect any change in the Company’s expectations with
regard thereto, or any change in events, conditions or circumstances on
which any such statement, forecast or estimate is based, except to the
extent required by French law.